Instrument Qualification

Hi

How do you determine which pieces of equipment, tools, jigs and fixtures, require an IQ and those that do not?

This is in relation to medical device manufacturing.

Thank you in advance.

Hello Milas,

• Are you 17025? If yes, what is listed in your scope?
• What requirements do your customers specify?

Much relies on the responses to the above. Please consult with your customer to identify exactly what is required, and then consult with your organization engineers to establish and document (very important) conformance to XYZ requirements.

Jen Kirley said:

Hello Milas,

• Are you 17025? If yes, what is listed in your scope?
• What requirements do your customers specify?

Much relies on the responses to the above. Please consult with your customer to identify exactly what is required, and then consult with your organization engineers to establish and document (very important) conformance to XYZ requirements.

Click to expand...

those two points are from perspective of "process and business" ;
however, from systems perspective, its only reasonable to establish the IQ wrt to design criteria ( usually tied with OEM OR the URS relevant for the product/ process ) ; and followed by the evaluation of any-specific-criteria of customer or ISO criteria/relevance of scope.